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Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
alpha lipoic acid
Cellulose
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring pre-diabetes, glucose, insulin, blood lipids, alpha lipoic acid

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sedentary individuals (exercises < 2 days/week)
  • fasting blood glucose between 100-125 mg/dl (pre-diabetes)
  • BMI of 25-40.

Exclusion Criteria:

  • physically active lifestyle (exercise > two days/week)
  • pregnancy
  • history of cigarette smoking
  • medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control Phase

    Experimental Phase

    Arm Description

    cellulose (600 mg)

    alpha lipoic acid (600 mg)

    Outcomes

    Primary Outcome Measures

    Glycemic control
    blood glucose and insulin

    Secondary Outcome Measures

    Blood lipids
    Blood cholesterol
    Blood lipids
    Triglycerides

    Full Information

    First Posted
    July 16, 2018
    Last Updated
    November 27, 2020
    Sponsor
    State University of New York at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03612037
    Brief Title
    Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
    Official Title
    Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    December 30, 2018 (Actual)
    Study Completion Date
    December 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans. The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PreDiabetes
    Keywords
    pre-diabetes, glucose, insulin, blood lipids, alpha lipoic acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Phase
    Arm Type
    Placebo Comparator
    Arm Description
    cellulose (600 mg)
    Arm Title
    Experimental Phase
    Arm Type
    Experimental
    Arm Description
    alpha lipoic acid (600 mg)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    alpha lipoic acid
    Intervention Description
    600 mg/day oral dose of alpha lipoic acid
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Cellulose
    Intervention Description
    600mg/day oral dose of placebo cellulose
    Primary Outcome Measure Information:
    Title
    Glycemic control
    Description
    blood glucose and insulin
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Blood lipids
    Description
    Blood cholesterol
    Time Frame
    1 month
    Title
    Blood lipids
    Description
    Triglycerides
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: sedentary individuals (exercises < 2 days/week) fasting blood glucose between 100-125 mg/dl (pre-diabetes) BMI of 25-40. Exclusion Criteria: physically active lifestyle (exercise > two days/week) pregnancy history of cigarette smoking medication and/or dietary supplement to control blood glucose, lipids, or blood pressure.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Impact of Alpha-Lipoic Acid Ingestion on Glucose Tolerance in Subjects With Pre-Diabetes

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